LymphomaPhase 2NCT00493454
Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20+ Indolent Lymphomas
A Phase 2 study testing Zevalin, Rituximab and ^111 In Ibritumomab Tiuxetan in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: Overall Response Rate (ORR). Secondary Objectives: The Duration of Response (DR) and Time to Treatment Progression (TTP) in all patients and in the responders. Complete Responses (CR)/Complete Responses unconfirmed (CRu), and Partial Responses (PR). Time to next anticancer therapy (TTNT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Zevalin, Rituximab and ^111 In Ibritumomab Tiuxetan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No anti-cancer therapy for three weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from acute toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy.
- Previously treated patients with a histology of refractory/relapsed indolent lymphomas including: (a) Extranodal marginal lymphoma of MALT type; (b) Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells); (c) Splenic marginal B-cell lymphoma (+/- villous lymphocytes).
- Signed informed consent
- Age >/= 18 years
- Expected survival >/= 3 months
- Pre-study Zubrod performance status of 0, 1, or 2
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- Acceptable hematologic status within two weeks prior to patient registration, including: (a) Absolute neutrophil count ([segmented neutrophils + bands] * total white blood count (WBC)) >/= 1,500/mm^3; (b) Platelet counts >/= 100,000/mm^3.
- Female patients who are not pregnant or lactating
- Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician)
- Patients previously on Phase II drugs if no long-term toxicity is expected, and the patient has been off the drug for eight or more weeks with no significant post treatment toxicities observed
- Patients determined to have < 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy) (This criteria must be strictly met for adequate patient safety.)
- Patient should have at least one lesion measuring >/= 2 cm in a single dimension.
Who cannot join
- Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue.
- Platelet count< 100,000 cells/mm^3.
- Presence of hypocellular bone marrow.
- Patients with history of failed stem cell collection.
- Prior radioimmunotherapy
- Presence of Central Nervous System (CNS) lymphoma
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- Patients with HIV.
- Patients with pleural effusion
- Patients with abnormal liver function: total bilirubin > 2.0 mg/dL
- Patients with abnormal renal function: serum creatinine > 2.0 mg/dL
- Patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional)
- Patients who have received short-acting growth factor support (Leukine, Neupogen, Procrit) within 2 weeks prior to treatment or long-acting growth-factor support (Aranesp), Neulasta) within 4 weeks prior to treatment.
- Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives
- Major surgery, other than diagnostic surgery, within four weeks
- Evidence of transformation in the latest biopsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Phase II Study for Zevalin® in Patients With Relapsed/Refractory Indolent Lymphomas: Extranodal Marginal Lymphoma of MALT Type, Nodal Marginal Zone B-Cell Lymphoma, and Splenic Marginal B-Cell Lymphoma
Primary Objective:
- Overall Response Rate (ORR).
Secondary Objectives:
- The Duration of Response (DR) and Time to Treatment Progression (TTP) in all patients and in the responders.
- Complete Responses (CR)/Complete Responses unconfirmed (CRu), and Partial Responses (PR).
- Time to next anticancer therapy (TTNT).
Read the detailed description
^90 Y Ibritumomab tiuxetan and rituximab are both designed to attach to lymphoma cells, causing them to die.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a physical exam. Your blood (about 2 to 3 teaspoons) and urine will be collected for routine tests. You will have a chest x-ray and computerized tomography (CT) scans of the neck, chest, abdomen, and pelvis. You will have a bone marrow aspirate and biopsy performed. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood pregnancy test.
The study doctors will first make sure that your disease has not spread too much and is not too severe to require immediate treatment with chemotherapy before you can begin treatment on this study. If you are found to be eligible to take part in this study, you will be given Benadryl (diphenhydramine) by vein, and you will be given Tylenol (acetaminophen) by mouth before each dose of rituximab. This is done to help decrease the risk of developing side effects of rituximab. You will then receive 1 dose of rituximab by vein over 6 to 8 hours on Day 1 of treatment. After treatment with rituximab, you will then be given a radioactive antibody, ^111 In Ibritumomab tiuxetan (this is a radioactive agent that binds to rituximab to help with imaging exams), by vein over about 10 minutes. This is so researchers can use a special camera to see where the drug is in your body.
You will have imaging performed (with the special camera) on Day 1 and on either Day 2 or Day 3. On Day 8, you will receive a second dose of rituximab. This will then be followed by a dose ^90 Y Ibritumomab tiuxetan of given by vein over 10 minutes. This completes the treatment.
If you experience intolerable side effects while on this study, you may be removed from this study. The study doctor will then offer other treatment options to you.
For your follow-up, you will have blood (about 2 tablespoons) drawn once a week for the first 3 months, then every 3 months for 1 year, and then every 4 months for the second year. At these visits, you may also have CT scans, x-rays, and bone marrow biopsies and aspirates performed, if needed.
This is an investigational study. ^90 Y Ibritumomab tiuxetan and rituximab have been approved by the FDA for the treatment of indolent B-cell lymphoma. Up to 35 patients will take part in this multicenter study. Up to 15 will be enrolled at M. D. Anderson.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZevalinDrug
Also called Ibritumomab Tiuxetan
.3 mCi IV Over 10 Minutes x 1 Day
RituximabDrug
250 mg/m^2 IV Over 6 to 8 Hours
^111 In Ibritumomab TiuxetanDrug
Also called Indium-111
1.6 mg IV Over 10 Minutes x 1 Day
| Study group | Role | What they receive |
|---|---|---|
| Ibritumomab tiuxetan + Rituximab | Experimental | Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab. Receives: Drug: Zevalin; Drug: Rituximab; Drug: ^111 In Ibritumomab Tiuxetan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective response rate (ORR) = number of participants out of all participating with Complete Response (CR) + Partial Response (PR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. Response assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scans, every 3 months for the first year and every 6 months up to 3 years following.
Measured: Evaluation 4 weeks after administration of Zevalin up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startApr 2006
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Felipe Samaniego, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493454
- Sponsor's protocol ID
- 2005-0571
- Status last verified
- May 2013
- First submitted
- 27 Jun 2007
- Last updated
- 31 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study for Zevalin® in Patients With Relapsed/Refractory Indolent Lymphomas: Extranodal Marginal Lymphoma of MALT Type, Nodal Marginal Zone B-Cell Lymphoma, and Splenic Marginal B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00493454
- Acronym / sponsor ID
- 2005-0571
- Conditions
- Lymphoma
- Keywords
- Indolent Lymphoma, Extranodal Marginal, Nodal Marginal Zone, Splenic Marginal, MALT Type, Zevalin, Ibritumomab Tiuxetan, Rituximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Apr 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Posted 31 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- Overall Response Rate (ORR).
Secondary Objectives:
- The Duration of Response (DR) and Time to Treatment Progression (TTP) in all patients and in the responders.
- Complete Responses (CR)/Complete Responses unconfirmed (CRu), and Partial Responses (PR).
- Time to next anticancer therapy (TTNT).
Detailed description
^90 Y Ibritumomab tiuxetan and rituximab are both designed to attach to lymphoma cells, causing them to die.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a physical exam. Your blood (about 2 to 3 teaspoons) and urine will be collected for routine tests. You will have a chest x-ray and computerized tomography (CT) scans of the neck, chest, abdomen, and pelvis. You will have a bone marrow aspirate and biopsy performed. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood pregnancy test.
The study doctors will first make sure that your disease has not spread too much and is not too severe to require immediate treatment with chemotherapy before you can begin treatment on this study. If you are found to be eligible to take part in this study, you will be given Benadryl (diphenhydramine) by vein, and you will be given Tylenol (acetaminophen) by mouth before each dose of rituximab. This is done to help decrease the risk of developing side effects of rituximab. You will then receive 1 dose of rituximab by vein over 6 to 8 hours on Day 1 of treatment. After treatment with rituximab, you will then be given a radioactive antibody, ^111 In Ibritumomab tiuxetan (this is a radioactive agent that binds to rituximab to help with imaging exams), by vein over about 10 minutes. This is so researchers can use a special camera to see where the drug is in your body.
You will have imaging performed (with the special camera) on Day 1 and on either Day 2 or Day 3. On Day 8, you will receive a second dose of rituximab. This will then be followed by a dose ^90 Y Ibritumomab tiuxetan of given by vein over 10 minutes. This completes the treatment.
If you experience intolerable side effects while on this study, you may be removed from this study. The study doctor will then offer other treatment options to you.
For your follow-up, you will have blood (about 2 tablespoons) drawn once a week for the first 3 months, then every 3 months for 1 year, and then every 4 months for the second year. At these visits, you may also have CT scans, x-rays, and bone marrow biopsies and aspirates performed, if needed.
This is an investigational study. ^90 Y Ibritumomab tiuxetan and rituximab have been approved by the FDA for the treatment of indolent B-cell lymphoma. Up to 35 patients will take part in this multicenter study. Up to 15 will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibritumomab tiuxetan + Rituximab | Experimental | Drug: Zevalin, Drug: Rituximab, Drug: ^111 In Ibritumomab TiuxetanRituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- No anti-cancer therapy for three weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from acute toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy.
- Previously treated patients with a histology of refractory/relapsed indolent lymphomas including: (a) Extranodal marginal lymphoma of MALT type; (b) Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells); (c) Splenic marginal B-cell lymphoma (+/- villous lymphocytes).
- Signed informed consent
- Age >/= 18 years
- Expected survival >/= 3 months
Key exclusion criteria (15 listed)
- Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue.
- Platelet count< 100,000 cells/mm^3.
- Presence of hypocellular bone marrow.
- Patients with history of failed stem cell collection.
- Prior radioimmunotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZevalinAlso: Ibritumomab Tiuxetan.3 mCi IV Over 10 Minutes x 1 Day | Drug | Ibritumomab tiuxetan + Rituximab |
| Rituximab250 mg/m^2 IV Over 6 to 8 Hours | Drug | Ibritumomab tiuxetan + Rituximab |
| ^111 In Ibritumomab TiuxetanAlso: Indium-1111.6 mg IV Over 10 Minutes x 1 Day | Drug | Ibritumomab tiuxetan + Rituximab |
Primary outcome
Objective Response Rate
Time frame: Evaluation 4 weeks after administration of Zevalin up to 3 years
Objective response rate (ORR) = number of participants out of all participating with Complete Response (CR) + Partial Response (PR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. Response assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scans, every 3 months for the first year and every 6 months up to 3 years following.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Texas M.D.Anderson Cancer Center Official Web SiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Samaniego, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zevalin, Rituximab and ^111 In Ibritumomab Tiuxetan in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Evaluation 4 weeks after administration of Zevalin up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2013.